Association Between Grade(B/C)of Stage III and IV Periodontitis and High Sensitivity C Reactive Protein Level in Serum and Oral Rinse Sample

NCT06997770 | Not Yet Recruiting DMC

• 1 other identifier: Neha Sahjlan PeriodonticsPGIDS
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

According to 2017 World Workshop of Periodontology , the level of high sensitivity C reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Hence, measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in gaining insight on the systemic burden of periodontal disease.

Conditions

hsCRP

Keywords

periodontits

Outcome Measures

Primary Outcomes (1)

• Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals

  Evaluation of hsCRP level in oral rinse samples and serum in 3 groups of systemically healthy individuals (periodontally healthy, stage III and stage IV grade B generalized periodontitis, stage III and stage IV grade C generalized periodontitis)

  12-14 months

Secondary Outcomes (2)

• Correlation of Probing pocket depth (PPD)and Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples.

  12-14 months

• Correlation of Bleeding on probing (BOP%)

  12-14 months

Study Arms (3)

generalized periodontitis STAGE III/IV , Grade B

29 systemically healthy individuals With stage III /IV and grade B

generalized periodontitis STAGE III/IV , Grade C

29 systemically healthy individuals With stage III /IV and grade C

Periodontally healthy individuals

29 systemically and periodontally healthy individuals

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Group 1: comprising of periodontally healthy individuals. 2. Group 2: comprising of individuals, diagnosed with stage III and stage IV grade B periodontitis (according to WWP 2017 classification periodontal disease ) 3. Group 3: comprising of participants, diagnosed with stage III and IV grade C periodontitis,

You may qualify if:

• Patients in the age group of (18-50 years)
• Presence of ≥ 20 natural teeth
• Ability and willingness to give written informed consent
• Patients belonging to 3 groups -periodontally healthy, stage III and stage IV grade B periodontitis, and stage III and stage IV grade C periodontitis .

You may not qualify if:

• Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years
• Smokers and alcoholics
• Pregnant females
• Presence of xerostomia
• Patients undergoing radiotherapy
• Having received professional periodontal treatment within the previous 6 months
• Having received antibiotic medication 3 months prior to study
• Periapical pathology or other oral inflammatory conditions
• Cognitive disability (interfering with ability to give sample)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Officials

• Dr Aditi Sangwan, MDS

  PGIDS ,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha Sahjlan, MDS

CONTACT

9821182607; nehasahjlan267@gmail.com

Dr Sanjay Tewari, MDS

CONTACT

94162259534; principal.pgids@uhsr.ac.in

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 30, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)